Clinical Sensitivity Verification Study of Circulating Tumor Cells Gene Mutation Detection From Advanced NSCLC Patients

Shanghai Pulmonary Hospital, Shanghai, China

Status: Unknown

Conditions: Circulating Tumor DNA; Advanced NSCLC; Circulating Tumor Cells

Treatments: Other: nonintervention

Study type: Observational

Funder types: Other

Identifiers

NCT04229121

CTC-FM

Details and patient eligibility

About

Verify the Coincidence rate between Circulating tumor cells (CTCs) and tumor tissue or Circulating tumor DNA (ctDNA) of advanced NSCLC patients with Driver gene mutation

Full description

1. Enrich CTCs from advanced Non-Small Cell Lung Cancer (NSCLC) patients with Driver gene mutation, and detect the Epidermal Growth Factor Receptor (EGFR) mutation, Anaplastic lymphoma kinase (ALK) fusion, ROS proto-oncogene receptor tyrosine kinase 1 (ROS1) fusion, RET proto-oncogene (RET) fusion and Mesenchymal-Epithelial Transition factor (MET) 14 exon skipping by Lung cancer Polymerase Chain Reaction (PCR) panel kit, and verify the mutation coincidence rate between CTCs and tumor tissue.
2. Enrich ctDNA from advanced NSCLC patients with Driver gene mutation, detect the EGFR mutation by PCR, and detect the ALK fusion, ROS1 fusion, RET fusion and MET 14 exon skipping by next generation sequencing (NGS), and compare the mutation coincidence rate between CTCs and ctDNA.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Female or male, 18 years of age or older
2. Histologically or cytologically proven diagnosis of advanced NSCLC patients without any target therapy or chemotherapy
3. Able to get tumor tissue gene (EGFR/ALK/ROS1/RET/MET skipping) testing results by Lung cancer Polymerase Chain Reaction (PCR) panel kit carried out in hospital
4. Signed and dated informed consent

Exclusion criteria

1. Combine with other tumor type
2. The investigator judges the situation that may affect the clinical search process and results

Trial design

100 participants in 2 patient groups

Driver gene mutation-positive

Description:

Screen the enrolled patients according to the admission criteria. The detection of lung cancer Polymerase Chain Reaction (PCR) panel kit in the hospital requires the use of tissue samples and the results show a Driver gene mutation positive.

Treatment:

Other: nonintervention

Driver gene mutation-negative

Description:

Screen the enrolled patients according to the admission criteria. The detection of lung cancer Polymerase Chain Reaction (PCR) panel kit in the hospital requires the use of tissue samples and the results show a Driver gene mutation negative.

Treatment:

Other: nonintervention